Frovatriptan 2.5mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Frovatriptan succinate monohydrate
Available from:
DE Pharmaceuticals
ATC code:
N02CC07
INN (International Name):
Frovatriptan succinate monohydrate
Dosage:
2.5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070401
Authorization number:
; PL 18799/2473

Frovatriptan 2.5mg Film-coated Tablets

Your medicine is known by the above name but will be referred to as

Frovatriptan throughout this leaflet.

Patient Information Leaflet

What is in this leaflet:

1) What Frovatriptan is and what it is used for

2) What you need to know before you take Frovatriptan

3) How to take Frovatriptan

4) Possible side effects

5) How to store Frovatriptan

6) Contents of the pack and other information

1) What Frovatriptan is and what it is used for

Frovatriptan

Film-coated

Tablets

contain

frovatriptan

frovatriptan

succinate

monohydrate),

which

belongs

group

medicines called triptans (also known as 5-HT1 receptor agonists).

Frovatriptan is used to treat migraine with or without aura (a temporary

subjective feeling before a migraine attack, which varies greatly from

person

person

which

affect

vision,

sense

smell,

hearing).

Frovatriptan should not be used to prevent migraines.

2) What you need to know before you take Frovatriptan

The diagnosis of a migraine episode must have been clearly established

by your doctor.

Do not take Frovatriptan:

if you are allergic to frovatriptan, or any of the other ingredients of this

medicine (listed in section 6)

if you have a heart problem such as heart failure or chest pains

(angina), or have already had a heart attack

if you have circulation problems in your legs that cause cramp-like

pains when you walk (peripheral vascular disease)

if you have had a stroke or a mini-stroke (also called a transient

ischaemic attack or TIA)

if you have moderate to severe high blood pressure. You may be able

to take Frovatriptan if your high blood pressure is mild and is being

treated

if you have severe liver disease

with

other

migraine

medicines,

including

those

which

contain

ergotamine, or with similar medicines such as methysergide, or with

other 5-HT

receptor agonists, such as sumatriptan.

Warnings and precautions

Talk to your doctor or pharmacist before taking Frovatriptan

Take

special

care

with

Frovatriptan

patient

with

cardiovascular risk factors, including if you are:

a heavy smoker or taking smoking-cessation medicines

a woman in post-menopause or a man over 40 years of age.

In these cases, ask your doctor for advice before taking Frovatriptan.

In some rare cases, symptoms such as chest pain and feeling of

heaviness may appear in patients on triptans, even in cases with no

history of cardiovascular diseases.

If you notice any of these symptoms, contact your doctor straight away

and do not take any further doses of this medicine.

Other medicines and Frovatriptan

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines.

Do

not

take

this

medicine

at

the

same

time

as

certain

other

medicines used to treat migraines:

especially

ergotamine

ergotamine

derivatives

(including

methysergide), sumatriptan or other 5-HT1 receptor agonists; a period

least

hours

must

observed

between

stopping

these

medicines and administering Frovatriptan 2.5 mg film-coated tablets.

Similarly, these medicines must not be administered within 24 hours of

administering Frovatriptan

particularly

other

triptans

(5-HT1

agonists,

such

sumatriptan,

almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Do not take this medicine, unless otherwise advised by your doctor, at

the same time as monoamine oxidase inhibitors (MAOI) type medicines

used to treat depression (iproniazid, isocarboxazid, tranylcypromine,

moclobemide).

Inform your doctor or pharmacist if you are taking oral contraceptives

(the

pill)

selective

serotonin

re-uptake

inhibitors

(citalopram,

fluoxetine, fluvoxamine, paroxetine, sertraline).

Taking

Frovatriptan

together

with

St

John's

Wort

(Hypericum

perforatum) is not recommended.

The combination of Frovatriptan with the above medicines (particularly

monoamine oxidase inhibitors, selective serotonin reuptake inhibitors

and St John's Wort) may increase the risk of serotonin syndrome (the

symptoms of this syndrome include: chills, sweating, agitation, muscle

tremor and spasm, nausea, fever and confusion).

have

doubts

about

other

medicines

Frovatriptan, ask your doctor or pharmacist.

Frovatriptan with food and drink

Frovatriptan may be taken with food or fasting, and always with plenty of

water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are

planning to have a baby, ask your doctor or pharmacist for advice before

taking this medicine.

Unless otherwise advised by your doctor, the use of Frovatriptan is not

recommended while pregnant or breast-feeding.

In any case, you should not breast-feed for 24 hours after taking the

medicine. The milk expressed during this period should be discarded.

Driving and using machines

Either the symptoms of migraine or your medicine may make you

drowsy. If you are affected, do not drive or use any tools or machines.

Frovatriptan contains lactose

Frovatriptan 2.5 mg Film-coated Tablets contain a small amount of a

sugar called lactose. If you have been told by your doctor that you have

intolerance

some

sugars,

contact

your

doctor

before

taking

Frovatriptan.

3) How to take Frovatriptan

Always take this medicine exactly as your doctor has told you. Check

with your doctor or pharmacist if you are not sure.

Take Frovatriptan as soon as possible after the onset of the migraine.

Do not use this medicine to prevent migraines.

The tablet must be swallowed whole with a large glass of water.

If you feel no relief after the first dose, a second dose must not be taken

during the same episode. Frovatriptan may be used for the next attack.

If you obtain relief after the first dose but pain re-appears within 24

hours, a second tablet may be taken, provided that you observe an

interval of at least 2 hours between the two doses.

Do not exceed the maximum dose of 5 mg in 24 hours (i.e. two tablets).

Prolonged use (repeated use over several days) of Frovatriptan is not

recommended, and may cause an increase in side effects and lead to

daily headaches requiring discontinuation of treatment. Consult your

doctor if you experience frequent or daily headaches, as a diagnosis of

headache due to medication misuse should be considered.

Use in children and adolescents

Frovatriptan should not be used in children and adolescents under 18

years.

Older people

There are limited data on the safety and efficacy in patients over 65

years, so Frovatriptan is not recommended in these patients.

If you take more Frovatriptan than you should

If you accidentally take more Frovatriptan than you should, consult your

doctor

pharmacist

immediately,

your

nearest

hospital

emergency department. Take any remaining tablets or this leaflet with

you.

The symptoms of overdose are: dizziness, drowsiness, vomiting, feeling

unwell and decreased heart rate.

If you stop taking Frovatriptan

No special precautions are necessary when stopping this treatment.

If you have any further questions on the use of this medicine, ask your

doctor or pharmacist.

4) Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

If you experience the following side effects you should contact your

doctor or go to the hospital straight away:

A feeling of pressure or pain in the chest, at times intense and which

could extend to the throat, may appear some minutes after taking the

medicine. If you notice these symptoms, contact your doctor and do not

take any further doses of this medicine.

The side effects reported during the clinical studies with Frovatriptan

were temporary, mild to moderate and spontaneously disappeared.

Certain symptoms reported as side effects could be attributed to the

migraine episode.

Some cases of allergic reactions to Frovatriptan have been reported,

manifesting as a rash, as well as a generalised severe allergic reaction

(anaphylaxis) which can cause breathing difficulties, increased heart rate

and palpitations.

In this case, contact your doctor immediately.

In addition to above the following side effects have also been

reported:

Common: may affect up to 1 in 10 people

nausea, dry mouth, indigestion, stomach pain

fatigue, chest discomfort (feeling of heaviness, pressure or tightness in

the chest)

headache, dizziness, pins and needles in arms and legs, reduced or

increased sensations of touch, extreme desire to sleep

hot flushes

tightness in throat

visual disorders

increased sweating.

Uncommon: may affect up to 1 in 100 people

taste

alteration,

tremor,

poor

concentration,

lethargy,

skin

hypersensitivity, drowsiness, involuntary muscle contractions

diarrhoea,

difficulty

swallowing,

bloatedness,

stomach

discomfort,

flatulence

increased heart rate, palpitations, high blood pressure, chest pain

(intense feeling of tightness or pressure in the chest)

feeling hot, decreased tolerance to hot and cold, pain, weakness,

fever, thirst, lack of energy, hyperactivity, feeling unwell, a feeling of

intoxication, dizziness

anxiety,

insomnia,

confusion,

agitation,

nervousness,

depression,

personality disorders, cold extremities

rhinitis, sinusitis, sore throat

muscle stiffness, bone and muscle pain, pain in hands and feet, joint

pain, back pain, eye pain, eye irritation, discomfort looking at light

pruritus

ringing in the ears, earache

dehydration

urinary urgency, increased urination

high blood pressure.

Rare: may affect up to 1 in 1,000 people

muscle spasms, decreased muscle tone, reduced muscle reflexes

(hyporeflexia), movement disorders

constipation, belching, heartburn, intestinal irritation, mouth ulcers, lip

pain, oesophageal spasm, gastro-duodenal ulcer, pain in salivary

gland, inflammation of the mouth, toothache

fever

memory loss, nightmares, personality disorders

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on

to others. It may harm them, even if their signs of illness are the

same as yours.

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. See

section 4.

nosebleeds, increased respiratory rate, hiccups, throat irritation

night blindness

purple marks on skin or mucous membranes, skin redness, hives,

goose bumps

bradycardia

hearing disorders, ear discomfort, itchy ears, sensitive hearing

increased

blood

bilirubin,

decreased

blood

calcium,

abnormal

urinalysis

hypoglycaemia

night-time urinary urgency, kidney pain

self-mutilation (such as biting, bruising)

enlarged lymph nodes

breast pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This

includes any possible side effects not listed in this leaflet. You can also

report

side

effects

directly

Yellow

Card

Scheme

www.mhra.gov.uk/yellowcard. By reporting side effects you can help

provide more information on the safety of this medicine.

5) How to store Frovatriptan

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the

blister and the outer carton after EXP. The expiry date refers to the

last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

tablets

become

discoloured

show

other

signs

deterioration, you should seek the advice of your pharmacist who will

tell you what to do.

6) Contents of the pack and other information

What Frovatriptan contains

The active substance is frovatriptan. Each tablet contains 2.5mg of

frovatriptan (as frovatriptan succinate monohydrate).

The other ingredients are:

Tablet

core:

silicified

microcrystalline

cellulose,

lactose

anhydrous,

silicon

dioxide,

sodium

starch

glycolate

(Type

magnesium

stearate.

Film-coating: hypromellose (E464), lactose monohydrate, macrogol 3350

(E1521), triacetin and titanium dioxide (E171).

Contains approximately 107mg of lactose per tablet.

What Frovatriptan looks like and contents of the pack

Frovatriptan 2.5mg Film-coated Tablets are white to off white round film-

coated tablets, plain on both sides.

They are available in blister packs of 6 tablets.

PL 46420/0009

Frovatriptan 2.5mg Film-coated Tablets POM

Who makes and repackages your medicine?

Your medicine is manufactured by Chanelle Medical, Loughrea, Co.

Galway, Ireland

JSC Grindeks, 53 Krustpils street, Riga, LV-1057, Latvia.

Procured from within the EU and repackaged by the Product Licence

holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road,

Northolt, Middlesex, UB5 5QS.

Leaflet date: 19.02.2020

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 020 8839 3000 to obtain the

leaflet

in

a

format

suitable

for

you.

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